Veterinary Sodium Chloride

Abbott Laboratories

FULL PRESCRIBING INFORMATION: CONTENTS*

• Description
• Clinical Pharmacology
• Veterinary Sodium Chloride Indications and Usage
• Contraindications
• Warnings
• Precautions
• Side Effects
• Dosage and Administration
• OverDosage
• How Supplied
• Directions for Use
• Principal Display Panel

FULL PRESCRIBING INFORMATION

For Animal Use Only    

Description

0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose plastic container for use as a sterile irrigating solution. No antimicrobial agent has been added. Discard unused portion. Composition, osmolarity, and ionic concentration are shown in Table 1:

The plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology

0.9% Sodium Chloride Irrigation, USP is useful as an irrigating fluid because the solution is isotonic, and provides a transparent fluid medium with optical properties suitable for good visualization of the irrigation site. During surgical procedures, the solution acts as a lavage for removing blood, tissue fragments, and bone fragments.

Veterinary Sodium Chloride Indications and Usage

0.9% Sodium Chloride Irrigation, USP is indicated for use as a sterile irrigating fluid.

Contraindications

None known.

Warnings

Not for injection.

Because fluids used for irrigation may be absorbed into the general circulation, solutions containing sodium ion should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Precautions

Because some of the fluid used for irrigation may be absorbed, caution must be exercised in the volume of irrigating fluid used especially with solutions containing the sodium ion in patients receiving corticosteroids or corticotropin.

Do not administer unless the solution is clear and the seal is intact.

Side Effects

If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Dosage and Administration

The volume of solution needed will vary with the nature and duration of the procedure.

If desired, warm in overpouch to near body temperature in a water bath or oven heated to not more than 45°C/113°F.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

OverDosage

In an event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings , Precautions  and Adverse Events .

How Supplied

0.9% Sodium Chloride Irrigation, USP in plastic container is available as follows:

List Number        Size (mL)        Code            NDC
04945-04-50        5000 mL          2B8209        0044-4945-50

Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

Directions for Use

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired.

Use Aseptic Technique.

1. Suspend container using hanger hole.
2. Remove protector from outlet port.
3. Attach irrigation set. Refer to complete directions accompanying set.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured for:
Abbott Laboratories
North Chicago, IL 60064

For customer service call (888) 299-7416

Printed in USA

07-19-69-402

Rev. August 2012

Principal Display Panel

NOT FOR INJECTION     04945-04-50
Veterinary 0.9% Sodium Chloride IRRIGATION, USP
5000 ml